1. Field of the Invention
The present invention relates to a method for configuring a clean room for the manufacture of pharmaceutical products, a method for the manufacture of pharmaceutical products using a navigation system, a computer program for carrying out the method, and a clean room.
2. Description of the Related Art
In general, production facilities for the manufacture of pharmaceutical or biopharmaceutical products are designed for less specific products, and the production facilities typically include well supervised, classified clean rooms in which acid-resistant, steel-clad devices are fixedly installed. In addition, the individual manufacturing steps required for the manufacture of a (bio)pharmaceutical product are mostly distributed to different clean rooms which are separated from one another.
In particular, the disadvantage of these production facilities is that they are very inflexible in adjusting to the manufacture of new/other products, for example, drugs or biopharmaceuticals, so that it requires a great effort to manufacture a new/other product. This circumstance is associated with that adjusting from one product to another requires a long planning process. Furthermore, it is disadvantageous that if a specific product is only to be manufactured for a short period of time, a great effort is still to be expended to respectively adapt the production facility. This particularly applies if a product is required upon short notice or urgently; however, subsequently the previous product is to be manufactured again.
A diversion from the conventional production facilities is, however, not possible without further action because the quality and safety standards are to be maintained. This particularly applies to aspects such as using the correct devices and materials so that the product is manufactured with the correct composition.
In other words, conflicting goals result from reducing the cost for providing the production facilities and reducing the risk of product defects.
Furthermore, a more flexible design of the production facilities requires very well trained and reliable personnel so that mistakes and human error are reduced to a minimum.
The malfunctioning of a production facility for (bio)pharmaceutical products may have severe consequences. In addition to the repercussions from loosing market shares or paying penalties, the malfunctioning of a production facility may also lead to bottlenecks in the supply or the wrong patient care owing to erroneous medication.
For this reason, one aspect of the present invention is to provide an opportunity which, on the one hand, enables to reduce the costs for providing production facilities and, on the other hand, enables to flexibly adjust production facilities to new products, reducing malfunctioning risks and manufacturing errors to a minimum.